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GXP and Business Process Services

For life sciences and quality-oriented organizations, the confluence of new technology, regulatory compliance, growth and consolidations makes for a fast-paced environment requiring associated changes in business processes. In such circumstances, companies with outdated business processes often find themselves tied up in bureaucratic knots.

This is why understanding how to streamline GxP and other business processes for optimal success is such a crucial step for organizations, especially before rolling out a software implementation. This understanding is especially necessary when transitioning from manual or semi-manual processes to automated processes such as those MasterControl provides.

MasterControl GxP and Business Process services help customers achieve their desired results by ensuring that processes automated with MasterControl solutions are defined and delivered to address all user requirements for optimal success. MasterControl’s Business Process consultants are experts in identifying areas of paper congestion and workflow inefficiencies that hinder productivity, and they are responsible for analyzing quality organizations’ business processes, recommending new ways to manage them and leading the way to automated systems that put customers back in control.

Below is an overview of MasterControl's GxP and Business Process services.

Business Process Consulting

To ensure that MasterControl software works in synchronization with a company’s processes, MasterControl provides business process consultation for optimum business process management and expert development that ensures business processes can meet all user requirements.

MasterControl’s Business Process Consulting service focuses on investigating requirements for GxP or business processes and then creating a best practices-based design that includes forms and other elements necessary to enable the defined process. MasterControl’s experts meet with the customer’s staff – often employees in IT, quality, regulatory compliance, manufacturing and finance – to review business flows and determine better ways to accomplish organizational goals. Once requirements are gathered onsite, a design is created incorporating the necessary forms to enable the defined process.

MasterControl’s Business Process Consulting service delivers a detailed design document that provides clear specifications necessary for the successful implementation of a process. Better still, customers who choose one of MasterControl’s best practices-based solution packages are positioned to achieve optimal results with minimal changes while eliminating the need for a detailed design document.

Business Process Implementation

Best-practices implementation services are organized, managed and completed by the MasterControl project office to provide maximum value for customers’ investment based on best practices tailored to customers’ needs.

MasterControl’s Business Process Implementation service is designed to help customers create, implement, change and/or test a GxP or business process where the requirements have been defined. Business Process Implementation service options include installing and configuring the solution according to specific installation checklists; customization of the solution; troubleshooting, changing or updating existing operational business processes; and designing or implementing a new business process. This service can be provided either remotely or onsite, depending on customer needs and requirements.

MasterControl consultants work with customers through every step of implementation, engaging with the project team in analyzing problems, devising solutions and configuring the system to maximize efficiencies and minimize pains.

As with all MasterControl products and services, please feel free to contact us with any questions regarding our GXP and Business Process services.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.